Unibest

Pipeline Database

UB825

Rosuvastatin Calcium Tablet

UB825

ProductRosuvastatin Calcium Tablet
Strength5mg,10mg, 20mg, 40mg
IndicationsPrimary hypercholesterolaemia; Mixed dyslipidaemia; Homozygous familial hypercholesterolaemia
TherapeuticsMetabolic & Endocrinology
GMPUS - FDA; CN - NMPA; EU - EMA; PH - FDA​​
RegistrationChina; United States; EU; Philippines
ModalitiesSmall Molecule

Exclusive Summary

  • Rosuvastatin's patents have expired in all major markets (US, EU, Philippines), enabling immediate generic market entry without IP litigation risk through established distribution channels.
  • With over 1 billion people globally affected by dyslipidemia and CVD being the world's #1 killer (17.9 million deaths/year), rosuvastatin remains one of the highest-demand cardiovascular generics worldwide.
  • Triple GMP certification (US FDA + EU EMA + PH FDA) combined with existing registrations in the US, 27 EU countries, and the Philippines eliminates regulatory barriers, allowing distribution partners to launch sales immediately.
  • Generic rosuvastatin is priced 60%-95% below the originator Crestor, providing strong competitiveness in European public tenders, US GPO procurement, and price-sensitive emerging markets.
  • Full dosage strength portfolio (5mg/10mg/20mg/40mg) covers all clinical scenarios from low-dose initiation to high-intensity statin therapy, fitting diverse prescribing practices across markets.

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